Cleared Traditional

Carto Octaray Mapping Catheter with Trueref Technology

K193237 · Biosense Webster, Inc. · Cardiovascular
Jul 2020
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K193237 is an FDA 510(k) clearance for the Carto Octaray Mapping Catheter with Trueref Technology, a Catheter, Intracardiac Mapping, High-density Array (Class II — Special Controls, product code MTD), submitted by Biosense Webster, Inc. (Irvin, US). The FDA issued a Cleared decision on July 31, 2020, 249 days after receiving the submission on November 25, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K193237 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2019
Decision Date July 31, 2020
Days to Decision 249 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MTD — Catheter, Intracardiac Mapping, High-density Array
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1220

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